If your time is short:
Advances in pharmaceutical research continue to save lives, alleviate pain, and prevent disease. One result of such progress is a continuous evolution in how the safety and efficacy of these incredible medicines are monitored.
Here, we reveal how numerous major health organizations and regulatory agencies have responded to the many increased complexities in maintaining high standards of Good Pharmacovigilance Practices (GVP).
Need access to the industry's best drug safety experts? Learn more about our Clinical Operations staff augmentation and recruitment services.
What is Pharmacovigilance? A Brief Overview
The concept of pharmacovigilance—derived from the Greek and Latin 'Pharmakon' (medicinal substance) and Vigilia (to keep watch)—emerged in earnest among physicians and other health experts almost 200 years ago. Initially, the practice amounted primarily to letters and reports written by physicians on the safety and effectiveness of various drugs given to their patients.
Today, the World Health Organization (WHO) defines pharmacovigilance as “The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.”
WHO specifies that any newly developed drug must meet three critical conditions prior to approval by its respective regulatory agency: good quality; effectiveness; safety for intended purpose(s).
The scope of pharmacovigilance has broadened dramatically within recent years. WHO now includes the following:
- Interactions of medicines
- Abuse and misuse of medicines
- Counterfeit medicines
- Medication errors
- Adverse drug reactions/events
- Lack of efficacy
Medicines are not the only products considered under the purview of pharmacovigilance practice, but also:
- Blood products
- Medical devices
- Traditional/Complementary substances
The growth of consumer advocacy practices and increased attention to public health, combined with increased regulatory oversight, underscore the importance of consistent sets of pharmacovigilance strategies.
Not only is high-quality pharmacovigilance now critical to successful pharmaceutical premarket review, but also post-market surveillance.
Due to this expansion in scope, complexity, and responsibility, these are now more commonly referred to as Good Pharmacovigilance Practices (GVP).
The European Medicines Agency's Expectations for Good Pharmacovigilance Practice
In 2012, the EMA presented specific sets of principles and processes drawn to pursue further improvements in GVP. As a regulatory authority of the European Union (EU), they are tasked with overseeing post-marketing activities. This is a much broader purview than that of the FDA, which regulates post-marketing surveillance.
Some EMA expectations include improvements to the Eudravigilance database to increase reporting; stakeholder engagement, transparency, and a centralized platform for training and education.
The principle activities of the EMA include the provision of science-based recommendations; implementing measures to ensure that benefits of medicines outweigh risks; and developing best practice for drug evaluation.
- EMAs' Regulatory Information
- EMA's Marketing Authorization
The Food and Drug Administration's Expectations for Good Pharmacovigilance Practice
It's notable that the EMA and FDA chose to participate in collaborative processes for information-sharing on GVP. In 2014, they formed a "cluster’ relationship." This is intended to share data, research, and coordinate other activities.
The two agencies have a number of shared values. These include increased emphasis on transparency, evidence-based post-market decision making, and high levels of accountability.
Although the FDA has expectations in relation to reporting serious adverse drug reactions (ADR), there are not mandatory requirements on the specifics of post-market surveillance. The main focus of the FDA regarding GVP is guidance on the documentation of safety signals and development of high-quality case reports.
The FDA also recommends exploring causal relationships between the use of a drug and the ADR, and using data-mining to identify potential product-event combinations.
Health Canada Expectations for Good Pharmacovigilance Practice
Canadian health officials implemented GVP in 2004. The Health Products and Food Branch Inspectorate outlined numerous expectations regarding the reporting of adverse drug reactions and post-approval reporting requirements when conducting inspections.
They outlined several responsibilities of the Market Authorization Holder (MAH), including but not limited to complaints procedures and reporting of unusual failure of new drugs.
The reporting of suspected ADRs is critical to patient safety and is therefore the responsibility of all health care professionals, especially pharmacists. Health Canada does not require health professionals to be certain of a direct cause-effect relationship when reporting and ADR.
- Health Canada's GVP Guidelines
- Health Canada's Risk Classification and GVP
The Role of Consultants & Contracted Resources in Ensuring GVP Compliance
Good Pharmacovigilance Practice is decidedly different in the 21st century. As discoveries of new vaccines, drugs, and biologics fly into awareness at the speed of light, industry leaders are challenged to keep up. They are also continuously confronted by the immense expansion of pharmacovigilance as a separate science.
Meeting Specialized Work Requirements
It’s no longer about simply exploring, reporting, and addressing adverse events. On the contrary, it’s about study design, outcomes, product labelling, and data mining. Information gathering can (and should) include hospitals and clinicians.
Essentially, it’s about the inclusion of real-world data. When it comes to ensuring GVP compliance, one researcher aptly asked, “With these worries in mind, what level of staffing and training is needed to adequately and appropriately handle modern-day demands for pharmacovigilance.”
Specialized consultants can fulfill the need created by this 20th century new science called pharmacovigilance.
Their expertise includes analyzing safety signals, writing case reports, data mining, and even performing literature reviews. According to the FDA's Guidance on GVP, the identification and proper interpretation of ‘safety signals’ are a very large part of good pharmacovigilance.
‘Safety signals’ are defined as an excess of adverse events in relation to what might be expected for that particular product.
From these reports is then developed ‘case reports’ and ‘case series.’ The process is lengthy and tedious, but the identification of adverse events is necessary to the FDA regulations of mandatory reporting.
Navigating Multiple Regulatory Environments
Multiple international regulations can play a pivotal role in how pharmacovigilance goals are achieved. Although this is an excellent opportunity to collaborate global neighbors, it takes a specific skill set to synthesize the various regulations and guidelines.
By the same token, it’s extremely important to know when regulations are just simply not the same. For example, post-approval safety studies are treated very differently in the EU as opposed to the US (where the closest parallel would be post-market requirements). The well-trained, experienced consultant will aid managers in determining which regulations may take precedence, and for what reason.
An organization may find itself needing to prepare for a GVP audit either due internal quality control decisions, or external requirements. Any consultant must be well-versed in international regulations (not just the FDA) and have a toolset of best practices informed through work in the field.
Conclusion and Next Steps
Leaders in the pharmaceutical, medical device and biologic industries have a great deal to consider when they think of GVP. The risk versus benefit ratio of any drug therapy is always high on the list of major concerns. There is major benefit in procuring the expertise of a seasoned professional who specializes in the niche discipline of pharmacovigilance.
A closer look at this short-term, contingency-based consultant is worth the time. They will supply their hosting organization with high-performing dedication from day one. They are also guaranteed to always put patient safety first.
Connect with the industry's best drug safety experts.
Our safety and pharmacovigilance resources utilize a deep knowledge of regulatory legislation and a focus on quality safety to provide effective solutions for compliant global pre- and post-approval pharmacovigilance. Learn more about our Clinical Operations staff augmentation and recruitment services.
Work alongside experienced pharmacovigilance resources to support clinical trial and post-marketing safety surveillance throughout the clinical trial and post-marketing/commercialization phases of your product lifecycle.
Our pharmacovigilance resources can manage a variety of safety, quality, and compliance activities including, but not limited to:
- Clinical trial safety
- Post-marketing safety
- Regulatory submissions for safety
- Safety physicians
Learn more about our pharmacovigilance auditing, staff augmentation, and recruitment services and contact us to start the conversation today.
FREE WHITE PAPER
The Life Science Quality Leadership Report & Benchmark
Grab our free report get a unique look into how quality leaders are preparing for the future through the decision they're making today. We reveal trending quality objectives, challenges, and more.